Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants. (DIETCHIRCARD)

Queen Fabiola Children's University Hospital

Status: Terminated

Conditions: Congenital Heart Disease in Children

Treatments: Dietary Supplement: Nutrilon without lactose® fortified by concentration; Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03136900

P2017/PICU/DIETCHIRCARD

Details and patient eligibility

About

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.

After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.

The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.

Enrollment: 41 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation
• Expected stay of 5 days in PICU after surgery
• Expected need of invasive ventilation for 48h after surgery
• Expected need for enteral feeding during 5 days.
• Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study

Exclusion criteria

• Medical indications for specific diet
• ECMO
• Dialysis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

Study Diet

Experimental group

Description:

Enteral diet made of Nutrilon without lactose® fortified by concentration

Treatment:

Dietary Supplement: Nutrilon without lactose® fortified by concentration

Control Diet

Active Comparator group

Description:

Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.

Treatment:

Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation